Erlotinib Hydrochloride in Reducing Duodenal Polyp Burden in Patients With Familial Adenomatous Polyposis at Risk of Developing Colon Cancer

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02961374
Phase
PHASE2
Status
Completed

Conditions

  • Attenuated Familial Adenomatous Polyposis
  • Familial Adenomatous Polyposis

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This phase II trial studies the side effects of erlotinib hydrochloride and how well it works in reducing duodenal polyp burden in patients with familial adenomatous polyposis at risk of developing colon cancer. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.

Key Dates

First listed
Nov 11, 2016
Start date
Oct 27, 2017
Status verified
Jul 2022
Primary completion
Feb 23, 2020
Completion
Sep 27, 2021

Study Design

Enrollment
46 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Treatment (erlotinib hydrochloride)
    Patients receive erlotinib hydrochloride PO once weekly. Treatment continues for up to 6 months in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Mean Percent Change in Duodenal Polyp Burden [ Time Frame: Baseline to 6 months post-intervention ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo Clinic in ArizonaScottsdaleArizona85259-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
Mayo Clinic in RochesterRochesterMinnesota55905-
Cleveland Clinic FoundationClevelandOhio44195-
University of Pittsburgh Cancer Institute (UPCI)PittsburghPennsylvania15232-
M D Anderson Cancer CenterHoustonTexas77030-
Huntsman Cancer Institute/University of UtahSalt Lake CityUtah84112-

Find similar trials in Scottsdale, AZ

By research site
Mayo Clinic in Arizona· Scottsdale, AZUniversity of Michigan Comprehensive Cancer Center· Ann Arbor, MIMayo Clinic in Rochester· Rochester, MNCleveland Clinic Foundation· Cleveland, OHUniversity of Pittsburgh Cancer Institute (UPCI)· Pittsburgh, PAM D Anderson Cancer Center· Houston, TX

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